EMEA-000576-PIP01-09-M12

Key facts

Invented name
Xeljanz
Active substance
Tofacitinib
Therapeutic area
Immunology-Rheumatology-Transplantation
Decision number
P/0227/2020
PIP number
EMEA-000576-PIP01-09-M12
Pharmaceutical form(s)
  • Film-coated tablet
  • Prolonged-release film-coated tablet
  • Oral solution
  • Prolonged-release age-appropriate oral formulation
Condition(s) / indication(s)
Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis)
Route(s) of administration
Oral use
Contact for public enquiries
Pfizer Europe MA EEIG

Tel. +44 (0)1304 646 607
E-mail: pip_enquiries@pfizer.com
Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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